Characterization of the Genetic Profile of Type 2 Endometrial Carcinoma in Martinique

NCT ID: NCT03766672

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-11-22
• Study Completion Date: 2024-07-22

Brief Summary

In Martinique, about 33 new cases are diagnosed per year, with a high incidence rate of type 2 endometrial carcinoma which has a poor prognosis with few therapeutic options. Although targeted therapies are used in many types of cancer, they are still possible a minority of patients. In current practice, endometrial cancers do not benefit these therapies. Characterization of the molecular mechanisms involved in the genesis of type 2 endometrial carcinoma could help to identify biomarkers predictive of a response to targeted therapies. We propose to identify the genetic profile of type 2 endometrial carcinomas in Martinique.

Detailed Description

Type 2 endometrial carcinomas are often diagnosed at advanced stages, with an high risk of metastatic recurrence and death even when diagnosed at early stages. They also have few therapeutic options. The Characterize the mutations responsible of cancer development has led to develope "precision medicine" that targets "actionable genes" by a drug. This concept of actionable mutation refers to a change in the DNA molecule that can predict the response to a drug defined as targeted therapy. Although targeted therapies are used in many types of cancer, they still target a minority of patients. Some tumor sites still do not benefit from these treatments. Specifically, type 2 endometrial cancers that have poor prognosis with few therapeutic options. The characterization of molecular mechanisms, by Next Generation Sequencing (NGS), involved in the carcinogenesis of endometrial cancers, particularly type 2 cancers, should allow the identification of predictive biomarkers for response to certain targeted therapies.

Conditions

Endometrial Neoplasms

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Intervention Arm

Identify the genetic profile of type 2 endometrial carcinomas in Martinique from tumor sample for extraction of tumor DNA .

Intervention Arm

Intervention Type: DIAGNOSTIC_TEST

The intervention consists to the characterization of molecular mechanisms using to Next Generation Sequencing (NGS) technique.

Interventions

Intervention Arm

The intervention consists to the characterization of molecular mechanisms using to Next Generation Sequencing (NGS) technique.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Major subject living in Martinique with the following characteristics :

• Patients with type 2 endometrial cancer, with anatomopathological confirmation
• Affiliate or beneficiary of french social security.
• Free, informed with a written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any research required by the research).

Exclusion Criteria

• Type 1 adenocarcinoma
• Patients not affiliated to french social security
• Refusal to participate.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Martinique Cancer Registry

UNKNOWN

Sponsor Role: collaborator

University Hospital Center of Martinique

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medhi JEAN-LAURENT, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Martinique

Locations

Chu Martinique

Fort-de-France, , Martinique

Countries

Martinique

Other Identifiers

2018-A02091-54

Identifier Type: OTHER

Identifier Source: secondary_id

18_RIPH2_15

Identifier Type: -

Identifier Source: org_study_id